Senior Director, Regulatory Affairs – Product Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, validate, and manage global regulatory strategies for emerging technologies, product development, product registrations, lifecycle management, and market access.

• Direct portfolio-level regulatory planning for intricate high-risk devices, encompassing pathways, claims, labeling, evidence, timelines, resources, and approval risks.

• Act as the senior Regulatory Affairs representative to executive leadership, program governance, and cross-functional product development teams.

• Provide guidance on regulatory risks, trade-offs, and go/no-go decisions.

• Influence and manage opportunities related to emerging and acquired technologies while aiding integrations.

• Ensure timely and high-quality submissions to global regulatory authorities, including FDA pre-submissions, IDE, PMA, 510(k), PMA supplements, EU MDR technical documentation, CE Marking, deficiency responses, and international registrations.

• Lead and negotiate interactions with regulatory authorities, including FDA meetings, notified body evaluations, competent authority engagements, advisory panel preparations, formal correspondence, and deficiency resolutions.

• Advise on clinical evidence strategies that support global approvals.

• Interpret evolving global medical device regulations, standards, and guidance, assess the impact on the enterprise, and drive implementation strategies.

• Support global compliance initiatives.

• Collaborate with R&D, Clinical, Quality, Operations, Supply Chain, Marketing, Commercial, and Legal teams.

• Direct regulatory evaluations for new technologies, design modifications, labeling, claims, product discontinuations, partnerships, and business development opportunities.

• Contribute to commercial strategies and regional/corporate objectives.

• Build, manage, mentor, and succession-plan the Regulatory Affairs organization; set objectives, allocate resources, manage budgets, and establish metrics.

• Provide senior regulatory leadership during audits, inspections, escalations, field actions, and compliance issues.

⛳️ Requirements

• A bachelor's degree is required in science, engineering, life sciences, or a related field.

• A minimum of 12 years of experience in regulatory affairs or the medical device sector with a bachelor's degree, including significant leadership experience, OR a minimum of 10 years of experience with an engineering degree and a master's degree, including substantial leadership experience.

• Extensive experience in defining and executing global regulatory strategies for Class II/III and high-risk medical devices throughout new product development and lifecycle management.

• Demonstrated success in leading or significantly influencing successful submissions and approvals, including IDE, PMA, HDE, PMA supplements, EU MDR technical documentation/CE Marking, ANVISA, PMDA, and Health Canada registrations.

• Expertise in global medical device regulations, particularly those of the US FDA, EU MDR, Canada, Latin America, and Asia Pacific requirements.

• Experience in leading interactions and negotiations with the FDA, notified bodies, and global regulatory authorities.

• Ability to align regulatory strategy with clinical evidence generation, pivotal studies, benefit-risk assessments, labeling, claims, and commercialization strategies.

• Familiarity with US FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, design controls, and related medical device standards.

• Advanced analytical thinking and comprehension of engineering, physiology, device design, medical device usage, and software/digital components.

• Proven skills in program and portfolio management.

• Competencies in personnel development, succession planning, budget/resource management, and organizational design.

• High ethical standards, sound judgment, and the capability to lead through uncertainty while maintaining compliance, quality, and a focus on patient safety.

🏝️ Benefits

• Comprehensive health insurance plans.

• Retirement savings options with company matching.

• Generous paid time off and holiday policies.

• Opportunities for professional development and continuous learning.

• Flexible work arrangements to promote work-life balance.